1. Field of the Invention
The present invention relates generally to compositions and methods of using such compositions for the treatment of skin conditions, and more particularly to a method of using a dermatological composition comprising an aqueous solution containing boric acid and camphor or other terpenes for the treatment of onychomycosis.
2. Background Discussion
Onychomycosis is a fungal infection of the fingernails or toenails. The condition is difficult to cure. Onychomycosis occurs when dermatophytes (specifically, tinea unguium fungi) infect one or more nails. In the early stage of the infection, the area around the base and the sides of the nail may become red and irritated. If the fungus is allowed to spread deeper into the bed of the nail, it may cause discomfort, itching, and pain around the cuticles, and even bleeding and detachment of the cuticles. The nail may become discolored, perhaps yellow-green or dark yellow-brown, and white spots occasionally appear in the nail. Eventually, the nail thickens and develops abnormal grooves, lines, and broken and crumbling edges. Saprophytic molds, yeast and bacteria often co-infect or colonize the nail unit infected with dermatophytes to worsen the nail deformity and confound treatment in onychomycosis. This heterogeity of infecting microorganisms often explains treatment failure in that these different classes of microorganisms require differing antimicrobial agents to eradicate.
Tinea unguium fungi and co-infecting microorganisms thrive in warm, moist environments, so fungal nail infections generally develop under nails continually exposed to warm, moist environments, e.g., swimming pools, showers, and sweaty shoes. Predictably, infection in toenails is significantly more common than infection in fingernails, due to the fact that toenails are covered with shoes—creating the very kind of warm, moist environment in which fungi thrive. Relatively low blood circulation and slow nail growth rates may also be a contributing factor.
Nail fungal infections can be painful and may cause permanent nail damage. They can pose a serious health risk for people with diabetes or compromised immune systems.
Unfortunately, nail fungus can be difficult to treat, and recurrence is common. Over-the-counter antifungal nail creams, ointments and solutions are largely ineffective. Prescription medications are generally much more effective. The better known medications available by prescription include itraconazole (Sporanox); fluconazole (Diflucan); and terbinafine (Lamisil). However, these medications require an aggressive six to twelve week drug regimen or repeat courses of oral ingestion and may require four to twelve months to entirely eliminate an infection. Additionally, a typical twelve week course of treatment can cost upwards of $700 or more and still has only a 50-70% chance of curing the condition. Furthermore, these antifungal drugs may cause serious side effects, including liver damage, and monitoring of liver function by a physician is imperative. Adverse drug interactions also pose a serious risk for people on other systemic medicines.
For a relatively mild fungal nail infection, some doctors may prescribe an antifungal lacquer, such as ciclopirox (Penlac). This topical medication is painted onto the infected nails and surrounding tissue daily, so that several layers of lacquer build up over the course of a week. After one week, the seven layers are wiped off using an alcohol swab, and this is followed by another series of fresh applications. Studies show that this treatment is effective in less than 10 percent of patients using it.
If the nail infection is severe or extremely painful, a doctor may even recommend removing the nail during topical treatment. While a new nail will eventually grow in its place, the discomfort is not inconsiderable, and protection from injury and other invasive organisms is lost for a length of time.
Onychomycosis can be controlled and the appearance of the nails improved by applying undecylenic acid, which is approved by the FDA and is sold under a number of brand names, such as Blis-To-Sol Powder, Breezee Mist Foot Powder, Caldesene Powder, Cruex, Desenex, Fungoid AF, Pedi-Pro, and Protectol. This, however, is not a cure.
Numerous other methods have been proposed for the treatment of fungal nail infections. Patents showing compositions and their use in such treatments include U.S. Pat. No. 6,986,896, to Bhagwat , et al, which discloses a method of treating fungal conditions and onychomycosis through the administration of a safe and effective amount of urea in a topical formulation to an affected area on the skin or around a nail of a patient in need of treatment.
U.S. Pat. No. 6,960,201, to Cumbie, teaches a method of treating microbial infections occurring just below the skin and nails consisting of the application of electromagnetic radiation to an infected area of skin or nails for a time and at a proximity and intensity sufficient to render the microbes substantially inactivated and incapable of reproducing.
U.S. Pat. No. 6,951,847, to Gibson, et al, teaches a method of treating fungal and yeast infections using lupeol or solvates, hydrates, or clathrates.
U.S. Pat. No. 6,921,529, to Maley, shows a method of treating onychomychosis wherein a hydrogel is supersaturated with an antimycotic agent and supported on a backing The assembly is placed over an infected nail for an extended period of time. The antimycotic agent diffuses through the nail to the underlying infection. The antimycotic agent can be used alone or in conjunction with other active agents or carriers. Alternative therapeutic agents mentioned in the patent include iodine, DMSO, azole derivatives, undecylenic acid, tea tree oil, salicylic acid, urea, and any other recognized antimycotic agent.
U.S. Pat. No. 6,878,365, to Brehove, discloses a topical application for treating onychomycosis using a composition that comprises, as an active ingredient, at least one species selected from the group consisting of 2,2′-(alkyldioxy)bis-(alkyl-1,3,2-dioxaborinane) and 2,2′-oxybis(alkyl-1,3,2-dioxaborinane). The composition comprises, as an active ingredient, at least one member selected from the group consisting of 2,2′-(1-methyltrimethylenedioxy)bis-(4-methyl-1,3,2-dioxaborinane) and 2,2′-oxybis(4,4,6-trimethyl-1,3,2-dioxaborinane).
U.S. Pat. No. 6,846,837, to Maibach, et al, teaches a method and topical pharmaceutical formulations for the treatment of onychomycosis using a pharmacologically active antifungal agent, plus a pharmaceutically acceptable base in a formulation having a pH of 7.5 to about 13.0, preferably about 8.0 to 11.5, and most preferably about 8.5 to 10.5. The antifungal agent is selected from the group consisting of amorolfine, ciclopirox olamine, flucytosine, griseofulvin, haloprogrin, potassium iodide, sodium pyrithione, undecylenic acid, bifonazole, butoconazole, clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole, itraconazole, fluconazole, terconazole, naftifine, amphotericin B, nystatin, benzoic acid, salicylic acid, propionic acid, and caprylic acid.
U.S. Pat. No. 6,676,953, to Hexamer, discloses an antifungal composition for the treatment of fungal infections in human nails comprising an aqueous solution of a wetting agent such as alcohol and a source of fluoride ions sufficient to establish a pH ranging from about 2.8 to about 3.5 in the composition.
U.S. Pat. No. 6,664,292, to Bogart, teaches a method of treating pathological conditions of the nail comprising topically applying an effective amount of an optionally substituted lower alcohol and an optionally substituted lower carboxylic acid.
The foregoing patents and prior art methods are illustrative and exemplary only and reflect the current state of the art of which the present inventor is aware. Reference to, and discussion of, these patents is intended to aid in discharging Applicant's acknowledged duty of candor in disclosing information that may be relevant to the examination of prospective claims to the present invention. However, it is respectfully submitted that none of the above-indicated patents disclose, teach, suggest, show, or otherwise render obvious, either singly or when considered in combination, the invention described and claimed herein.